Nicotine patches used in combination with e-cigarettes (with and without nicotine) for smoking cessation: a pragmatic, randomised trial.

Introduction:
This text discusses a study on the effectiveness and safety of combining nicotine patches and second-generation e-cigarettes (with and without nicotine) on smoking abstinence. The study was conducted in a country with strong tobacco control measures and low e-cigarette use. The research questions addressed in this trial have informed tobacco control policy being developed by the New Zealand Ministry of health.

Key points:

* The study is a parallel group, community-based, pragmatic, three-arm, randomised trial.
* Participants were randomly assigned to receive nicotine patches, patches plus a nicotine e-cigarette, or patches plus a nicotine-free e-cigarette.
* Moderate-intensity behavioural support was available for all participants.
* The primary outcome was continuous smoking abstinence 6 months after the agreed quit date.
* The sample size was less than planned due to delays in sourcing nicotine e-liquid and slower than anticipated recruitment.
* Verified continuous abstinence at 6 months was significantly higher in the patches plus nicotine e-cigarette group (7%) than in the patches plus nicotine-free e-cigarette group (4%).
* No serious adverse events were treatment-related.
* The sponsor of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the report.

Main message:
The study found that combining reduced-harm nicotine products, such as nicotine patches with a nicotine e-cigarette, can lead to a modest improvement in smoking cessation over and above that obtained from using patches plus a nicotine-free e-cigarette (or patches alone), with no indication of any serious harm in the short-term. The findings suggest that future e-cigarette trials should focus on their use alone or in combination with usual smoking cessation support, given issues with differential loss to follow-up and withdrawal if a usual care group is used as a comparator.

Walker N, Parag V, Verbiest M, Laking G, Laugesen M, Bullen C. Nicotine patches used in combination with e-cigarettes (with and without nicotine) for smoking cessation: a pragmatic, randomised trial. The Lancet Respiratory medicine. 2020;8(1):54-64. doi:10.1016/S2213-2600(19)30269-3